With current policies, informed consent forms (ICF) are definitely too long and too scaring.

Prof. Vandenplas

Professor Yvan Vandenplas is a pediatric gastroenterologist at Universitair Ziekenhuis Brussel, the Dutch-language university hospital of Brussels. He is widely renowned for his research in drug and non-drug therapy in common childhood gastrointestinal disorders such as reflux disease and acute gastro-enteritis. Being head of the department pediatrics at Universitair Ziekenhuis Brussel, professor Vandenplas is involved in ongoing studies of our consortium at this university children’s hospital. We invited him to share his experiences in pediatric drug research.

“An important problem in pediatric gastroenterology is that we use lots of medication off-label. This creates dispute in issues like drug safety and side-effects as we prescribe drugs in a way that is officially not approved. We definitely need more adequately child-adapted pharmacological studies of drugs that are frequently used in childhood gastrointestinal disorders, but it is really tough to do.”

One of the drugs that professor Vandenplas has extensively studied in children is proton pump inhibitors, which are increasingly prescribed to children suffering from gastro-esophageal reflux. In setting up these studies, professor Vandenplas has experienced some difficulties in recruiting and consenting potential participants and their parents. “It is challenging to find children and parents who want to participate in drug studies since it are mostly not really new drugs under study. It is off course substantial to consent potential participants adequately. With current policies, informed consent forms (ICF) are definitely too long and too scaring. This is due to the common dilemma between giving potential participants complete information on the one hand but on the other hand you do not want to panic potential participants for very uncommon risks the study. This commonly ends up with recruiting a selected population for pediatric drug research.”

Professor Vandenplas is enthusiastic about the SAFE PEDRUG project group. “The project will certainly help to reduce off-label medication practices in children. Finding the right dose for children for example, particularly for the youngest ones, is a big problem if drug studies have not been adapted to children. Metabolism of most medications for young children is totally different from adults. This makes that I am looking forward to see the results of ongoing consortium studies. I hope that these results will contribute to improved pediatric drug studies in general.”